MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for MEDLINE DYND703060 manufactured by Medline Industries.
[123941185]
Sterile skin prep tray was opened and nurse found, what appeared to be, small cardboard pieces in the basin. It was removed from the pt care area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080548 |
| MDR Report Key | 7964989 |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-10-02 |
| Date Added to Maude | 2018-10-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDLINE |
| Generic Name | SKIN PREP TRAY |
| Product Code | OJU |
| Date Received | 2018-10-12 |
| Catalog Number | DYND703060 |
| Lot Number | 18FBD852 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Brand Name | MEDLINE |
| Generic Name | SKIN PREP TRAY |
| Product Code | OJU |
| Date Received | 2018-10-12 |
| Catalog Number | DYND703060 |
| Lot Number | 18FBD852 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-12 |